Sterilization tray for instruments

ABSTRACT

A system for storing instruments is provided. The system includes a tray including at least one tray end. At least one slot is formed in the at least one tray end. The system also includes a cover constructed and arranged to be positioned on the tray. The cover includes at least one cover end. The system also includes a latch positioned within the at least one cover end. The latch includes an actuating member and a locking member. The locking member includes at least one locking flange constructed and arranged to be received in the at least one slot. The at least one locking flange includes an angled lower edge constructed and arranged to engage the at least one tray end when the cover is positioned on the tray so that the latch is actuated into an open position to enable the at least one locking flange to be received within the at least one slot.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part application of, andclaims priority to, U.S. patent application Ser. No. 14/369,278, filedJun. 27, 2014, and having the title “STERILIZATION TRAY FORINSTRUMENTS,” the text and drawings of which are herein incorporated byreference in their entireties.

BACKGROUND

In the field of surgical instrument sterilization, sterilization trayshave traditionally been used to hold the surgical instruments fortransportation and sterilization. Conventional trays have employed metalbrackets riveted to a metal panel to cradle and secure each instrumentin place and to keep the instruments from contacting one another duringthe sterilization process. Securing and separating the instruments isimportant for the effectiveness of the sterilization process and furtherhelps maintain the instruments of a surgical kit in an organized andeasily selectable fashion. Conventional trays utilizing multiplebrackets for each individual instrument are generally very complex andrequire considerable time to manufacture and assemble because each typeof instrument may require a unique bracket arrangement. For example,conventionally each instrument may require at least two separatebrackets and four rivets. Moreover, due to the wide variety of surgicalkits used in the medical industry, each type of kit requires aspecialized set of brackets and other mounting hardware, which furtheradds to the cost and complexity of manufacturing trays for differenttypes of surgical kits.

Some sterilization trays are manufactured using polymer-based materials.Though these trays address some of the shortcomings described, thesetrays are not suitable for all sterilization processes. While themedical community in the United States typically uses high-pressuresaturated steam sterilization using an autoclave, other countries andregions prefer chemical sterilization. Such chemical sterilizationtechniques include immersion in a chemical bath of liquid sterilants oroxidizing agents such as the combination of hydrogen peroxide andperacetic acid, and aldehydes such as glutaraldehyde and, more recently,o-phthalaldehyde. The chemicals used for chemical sterilization areoften not compatible with the materials used for polymer-basedsterilization trays. Consequently, such trays are often not an option.

Accordingly, there is a need for a less costly, lighter weight, and moreversatile sterilization tray that is compatible with both steam andchemical sterilization processes.

BRIEF SUMMARY

The disclosure of the present application includes a sterilization trayfor instruments. In an exemplary embodiment of a sterilization tray ofthe present disclosure, the sterilization tray comprises a sheet havinga first end, an opposing second end, and a center portion between thefirst end and second end, in which the center portion comprising anundulating profile having a plurality of peaks and troughs and having aplurality of openings formed through the sheet. The openings arepositioned and configured to receive one or more instruments. The one ormore instruments comprises a set of surgical instruments. In at leastone embodiment, the center portion comprises a corrugated profile.Alternatively, the center comprises a saw-tooth or triangular profile.Alternatively, the distance between adjacent peaks of the center portiondefines a wave having a profile and a length, and the center portioncomprises a non-uniform profile comprised of one or more waves ofvarying lengths.

In at least one embodiment, the plurality of openings are formed suchthat the one or more instruments lie substantially on a plane across thepeaks and troughs of the center portion. The openings are further formedsuch that there is clearance between each opening and each of thecorresponding one or more instruments. The sheet further comprises aplurality of perforations formed through the sheet and arranged betweenthe openings. In at least one embodiment, the first end and second endare each formed at an angle such that a plurality of trays may bestacked one upon another. The tray further comprises at least onehandle. The at least one handle is formed integral with at least thefirst end or second end of the sheet such that it extends through andabove a top surface of the first end or second end and acts as anindexing feature where multiple trays are stacked.

In at least one embodiment, the tray further comprises a support frameattached to the sheet, the support frame having at least one handleformed therein. In at least one embodiment, the sheet includes indiciaimprinted on the sheet. The sheet is formed of a non-corrosive metal,such as stainless steel or aluminum. In at least one embodiment, thetray further comprises a hinged lid rotatable about the sheet andconfigured to be secured in a closed configuration by a latch.Alternatively, the tray comprises a cover disposed upon and removablyattached to the first end and second end of the sheet, the cover capableof substantially retaining the one or more instruments.

In at least one embodiment, the disclosure includes a kit of instrumentscomprising a tray having a sheet having a first end, an opposing secondend, and a center portion between the first end and second end, wherethe center portion is formed with an undulating profile having aplurality of peaks and troughs, and a plurality of openings formedthrough the sheet, where the openings are positioned and formed toreceive one or more instruments. The kit further includes a set ofinstruments each positioned within the plurality of openings such thatthe one or more instruments lie substantially on a plane across thepeaks and troughs of the center portion and a cover disposed upon andremovably attached to the first end and second end, the cover capable ofsubstantially retaining the set of instruments.

In one embodiment, a system for storing instruments is provided. Thesystem includes a tray including at least one tray end. At least oneslot is formed in the at least one tray end. The system also includes acover constructed and arranged to be positioned on the tray. The coverincludes at least one cover end. The system also includes a latchpositioned within the at least one cover end. The latch includes anactuating member and a locking member. The locking member includes atleast one locking flange constructed and arranged to be received in theat least one slot. The at least one locking flange includes an angledlower edge constructed and arranged to engage the at least one tray endwhen the cover is positioned on the tray so that the latch is actuatedinto an open position to enable the at least one locking flange to bereceived within the at least one slot.

BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned embodiments and other features, advantages anddisclosures contained herein, and the manner of attaining them, willbecome apparent and the present disclosure will be better understood byreference to the following description of various exemplary embodimentsof the present disclosure taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1A shows a perspective view of a sterilization tray forinstruments, according to an embodiment of the present disclosure;

FIG. 1B shows a plan view of a sterilization tray for instruments,according to an embodiment of the present disclosure;

FIG. 1C shows a side view of a sterilization tray for instruments,according to an embodiment of the present disclosure;

FIG. 1D shows a perspective view of a sterilization tray for instrumentsincluding an instrument set, according to an embodiment of the presentdisclosure;

FIG. 2A shows a perspective view of a sterilization tray forinstruments, according to an embodiment of the present disclosure;

FIG. 2B shows a perspective view of a sterilization tray forinstruments, according to an embodiment of the present disclosure;

FIG. 2C shows a perspective view of a sterilization tray for instrumentsincluding an instrument set, according to an embodiment of the presentdisclosure;

FIG. 3A shows a perspective view of a sterilization tray forinstruments, according to an embodiment of the present disclosure;

FIG. 3B shows a perspective view of a sterilization tray for instrumentsincluding an instrument set and cover, according to an embodiment of thepresent disclosure;

FIG. 4 shows a side view of two sterilization trays for instrumentsstacked upon one another, including an instrument set in each tray,according to an embodiment of the present disclosure;

FIG. 5 shows a perspective view of a sterilization tray for instrumentswith a support frame, according to an embodiment of the presentdisclosure;

FIG. 6 shows a perspective view of a sterilization tray for instrumentswith a support frame, according to an embodiment of the presentdisclosure;

FIG. 7A shows a perspective view of a sterilization tray for instrumentswith a support panel, according to an embodiment of the presentdisclosure;

FIG. 7B shows a plan view of a sterilization tray for instruments,according to an embodiment of the present disclosure;

FIG. 8A shows a perspective view of a sterilization tray for instrumentswith a hinged lid in a closed configuration, according to an embodimentof the present disclosure;

FIG. 8B shows a side view of a sterilization tray for instruments with ahinged lid in an open configuration, according to an embodiment of thepresent disclosure;

FIG. 9A shows a perspective view of a a sterilization rack forinstrument trays, according to an embodiment of the present disclosure;and

FIG. 9B shows a perspective view of sterilization trays for instrumentsdisposed in a sterilization rack, according to an embodiment of thepresent disclosure.

FIG. 10 shows a side view of a sterilization rack, according to anembodiment of the present disclosure.

FIG. 11 shows an end view of a sterilization rack and cover, accordingto an embodiment of the present disclosure.

FIG. 12 shows a top perspective view of a sterilization rack and coverin an open position, according to an embodiment of the presentdisclosure.

FIG. 13 shows a top perspective view of a sterilization rack and coverin a closed position, according to an embodiment of the presentdisclosure.

FIG. 14 shows a top perspective cut-away view of a sterilization rackand cover in a closed position, according to an embodiment of thepresent disclosure.

FIG. 15 shows a side cut-away view of a latch for a sterilization rackand cover in the closed position, according to an embodiment of thepresent disclosure.

FIG. 16 shows a side perspective cut-away view of a latch for asterilization rack and cover in a closed position, according to anembodiment of the present disclosure.

FIG. 17 shows a side perspective cut-away view of a latch for asterilization rack and cover in an open position, according to anembodiment of the present disclosure.

FIG. 18 shows an end perspective view of a sterilization tray having alatch in a closed position, according to an embodiment of the presentdisclosure.

FIG. 19 shows an end perspective view of a sterilization tray having alatch in an open position, according to an embodiment of the presentdisclosure.

FIG. 20 shows an end perspective view of a sterilization tray having alatch in a closed position to secure a cover shown in phantom, accordingto an embodiment of the present disclosure.

FIG. 21 shows an end perspective view of a sterilization tray having alatch in an open position with relation to a cover shown in phantom,according to an embodiment of the present disclosure.

Like reference numerals indicate the same or similar parts throughoutthe several figures.

An overview of the features, functions and/or configuration of thecomponents depicted in the various figures will now be presented. Itshould be appreciated that not all of the features of the components ofthe figures are necessarily described. Some of these non-discussedfeatures, such as various couplers, etc., as well as discussed featuresare inherent from the figures. Other undiscussed features may beinherent in component geometry and/or configuration.

DETAILED DESCRIPTION

The present application discloses various sterilization trays andmethods for using and constructing the same. According to one aspect ofthe present disclosure, a sterilization tray for instruments isdisclosed. For the purposes of promoting an understanding of theprinciples of the present disclosure, reference will now be made to theembodiments illustrated in the drawings, and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of this disclosure is thereby intended.

FIGS. 1A-1D depict a sterilization tray that can be used to retaininstruments. As shown in FIG. 1A, a sterilization tray 100 includes asingle sheet 110 having a first end 102 and a second end 103, positionedopposite one another, and a center portion 101 that joins the first andsecond ends 102, 103 together. As shown in FIG. 1C, the center portion101 may be formed into a corrugated or wave-like profile (i.e., in theside view) having a plurality of peaks 112 and troughs 114 along itslongitudinal axis running from the first end 102 to the second end 103.The first and second ends 102, 103 may be formed at an angle to thecenter portion 101 so as to extend above the peaks 112 and enablemultiple trays 100 to be stacked upon one another without contacting thepeaks 112 or troughs 114 of adjacent trays 100. A sub-portion of thecenter portion 101 extending from one peak 112 or one trough 114 to thenext respective peak 112 or trough 114 defines a wave 105 of a givenprofile and length. As used herein, the term “profile” refers to theshape when viewed from the side.

The center portion 101 may further include a plurality of openings 120formed through the sheet 110 defined by edges 122. As shown in FIG. 1B,the openings 120 may have various contours in plan view such that thesheet 110 is capable of both supporting and substantially retaining aplurality of surgical instruments 150 for organization, transportation,storage, handling and sterilization, as shown in FIG. 1D. Specifically,the openings 120 are formed to match the contour of each instrument 150in a set of instruments as that contour intersects each wave 105.Accordingly, as shown in FIG. 1D, where the width of an instrument 150in plan view is relatively large, the width of the corresponding opening120 is relatively large and vice versa. As a result, multiple openings120 may work in concert to support and substantially retain eachindividual instrument 150 at two or more locations as the instruments150 lie across the peaks 112 and troughs 114 of the sheet 110 and atleast partially in the openings 120. As used herein, the phrase “acrossthe peaks and troughs” is intended to mean intersecting the peaks 112and positioned above the troughs.

Moreover, because the openings 120 are formed to fit the contour of eachinstrument 150 of a set of instruments, each type of instrument 150 hasa specific intended location on the sheet 110, whereby the edges 122 ofthe openings 120 coincide with corresponding shape of an instrument 150where the instrument 150 is intended to lie across the peaks 112 andtroughs 114 of the sheet 110. Consequently, the tray 100 functions toboth retain and organize the instruments 150 for easy retrieval and useby a user. Further, the single sheet 110 with various openings 120 takesthe place of the numerous bracket components used in conventionalsterilization trays. It will be appreciated that any type and number ofinstruments may be retained by the tray 100, including but not limitedto surgical instruments used for hip replacement, knee replacement,dental surgery, etc.

The openings 120 may be formed such that a slight clearance distance ismaintained between the edges 122 of each opening 120 and thecorresponding surface of each instrument 150. The slight clearancedistance enables the instruments 150 to be freely placed unto andremoved from the tray 100 and to enable the free flow of sterilizationfluids around each instrument. For example, the opening 120 may beformed to be one-eighth inch larger than its corresponding instrument150 at the location where the instrument 150 contacts the sheet 110.However, the clearance distance between the edges 122 of each opening120 and the corresponding surface of each instrument 150 may beminimized to enable the tray 100 to retain all instruments 150 as thetray 100 is titled up to 45 degrees longitudinally, transversely, or ona compound angle between the longitudinal and transverse directions.

The sterilization tray 100 may be easily adapted to different instrumentsets via different configurations of the plurality of openings 120 inthe sheet 110. For example, an instrument set suitable for hipreplacement surgery will generally be different from one appropriate forshoulder surgery, which will generally be different from one appropriatefor dental surgery. Different configurations of the plurality ofopenings 120 may differ relative to the number, size, and contour of theopenings 120. As shown in FIG. 1C, the vertical distance between thepeaks 112 and the troughs 114 defines a height of the center portion101, and the height of the center portion 101 may be selected toaccommodate a given instrument set. Consequently, larger instruments 150may generally require a center portion 101 of greater height, andsmaller instruments may generally allow for a center portion 101 oflesser height. Similarly, the length of the wave 105 may also beselected to accommodate different sets of instruments, wherebyrelatively small instruments may be best supported by a tray 100 havinga relatively small wave length and vice versa. Thus, by varyingcombinations of the height of the center portion 101, the length andprofile of the wave 105, and the number, size, and contour of theopenings 120, separate embodiments of the tray 100 can be formed toaccommodate all manner of instrument sets. FIGS. 2A-2C, 3A-3B, 5, 6,7A-7B, and 8A-8B show sterilization trays 200, 300, 500, 600, 700, and800, respectively, each a different embodiment of the tray 100 fordifferent types of instrument sets.

Referring to FIG. 1D, a specific configuration (i.e., height of thecenter portion 101, length of the wave 105, and number, size, andcontour of the openings 120) of the tray 100 may be selected to supporteach instrument 150 of a set of instruments such that a topmost edge 152of each instrument 150 lies on the same plane, the plane lying below atop surface 118. Consistent and uniform positioning of the instruments150 to lie on a plane below the top surface 118 enables easy handling ofmultiple trays 100 simultaneously, enables trays 100 to be stacked ontop of one another within an autoclave without interference, and enablesan entire set of instruments 150 to be held securely in place when acover is attached to the tray 100 as disclosed more fully herein.Further, consistent and uniform positioning of the instruments 150 onthe same plane facilitates easy retrieval and use of the instruments 150by a user.

The wave 105 need not have a uniform sinusoidal profile as shown in FIG.1C. For example as shown in FIG. 2A, the profile of a center portion 201of a tray 200 could be comprised of triangular shaped waves 205.Alternatively, the wave 205 could have a substantially saw-tooth shapeas shown in FIG. 2B. Alternatively, the wave 205 could have a crescentshape, similar to a shark fin. In short, the wave 205 could assume anysuitable profile shape resulting in undulating peaks 212 and troughs214. Likewise, as shown in FIG. 2A, the overall profile of a centerportion 201 may include a combination of different profiles of waves 205defined by peaks 212 and troughs 214 to accommodate a particularinstruments set. Referring to FIG. 2C, some instruments 250 may best besupported for the purposes disclosed herein transversely across the tray200—that is, parallel to the peaks 212 and troughs 214. In suchapplications, the center portion 201 may instead include varyingcross-sectional profiles as further shown in FIG. 3A. Regardless of thecross-sectional profile of center portion 201, all instruments 250 of aninstrument set may be supported such that the topmost edge 252 of eachinstrument 250 lies on the same plane, the plane lying below a topsurface 218, as shown in FIG. 2C. Similarly, though the instruments 250are depicted lying longitudinally and transversely in the tray 200, oneof ordinary skill in the art having the benefit of this disclosure willrecognize that the plurality of openings 220 may be formed such that theinstruments 250 lie in a plane at any suitable attitude across the peaks212 and troughs 214 of the tray 200.

In at least one embodiment of the present disclosure, the center portion101 may further include a plurality of perforations 124 formed throughthe sheet 110 as shown in FIG. 1B. The perforations 124 may be circularin plan view as shown in FIG. 1B or may be any shape that enablessterilization fluids, such as super-heated steam, liquid sterilants, andoxidizing agents, to pass freely from one side of the sheet 110 to theother. Likewise, the perforations 124 may be arranged in any manner thatenables the free flow of sterilization fluids but does not interferewith structure and function of the openings 120.

The sterilization tray 100 may also optionally include at least one, andtypically two, handles 130 as shown in FIGS. 1A-1D. A handle 130 may bedisposed at each of the first and second ends 102, 103 and may extendthrough an opening 126 formed in the top surface 118 of each of thefirst and second ends 102, 103. For example, the handle 130 may extendone-half inch above the top surface 118. As shown in FIG. 1C, the handle130 may be a bail formed of a wire bent to form at least one retentionportion 134 below the top surface 118 and a loop portion 132 forgrasping above the top surface 118. During assembly of the handle 130into the first or second ends 102, 103, the loop portion 132 may beinserted through the opening 126, and the at least one retention portion134 bent such that the loop portion 132 and the retention portion 134are not in alignment, thereby trapping the handle 130 within the firstor second ends 102, 103.

In operation, the handle 130 may be lifted by a user until the retentionportion 134 contacts the underneath side of the top surface 118.Continuing the lifting motion then lifts the entire tray 100. Uponrelease, the handle 130 will drop back freely to a resting state due toits own weight. In a resting state, the retention portion 134 of thehandle 130 may rest on the center portion 101 such that the loop portion132 protrudes through the opening 126 in the top surface 118. Theprotrusion of handle 130 through the opening 126 may provide an indexingfeature when multiple trays 100 are stacked one upon another to maintainalignment and at least a partial interlock between trays 100. As shownin FIG. 4, a handle 430 of a lower tray 411 may protrude through acorresponding opening in a center portion 401 of an upper tray 410 andprovide positioning and interlocking connectivity between multiplestacked trays, such as upper tray 410 and lower tray 411.

As noted herein, a tray 300 may be made to accommodate an instrument setincluding large instruments 350 as shown in FIGS. 3A-3B. The overallheight of the tray 300, being the distance between a top surface 318 ofa first end 302 (or a second end 303) and a trough 314 of a centerportion 301 may be relatively large. In such embodiments, the first andsecond ends 302, 303 may each include at least one handle tab 319. Thehandle tab 319 may be formed by cutting and folding a section of thefirst or second ends 302, 303 toward the center portion 301 such that ahandle 330 may contact the handle tab 319 in a resting state, instead ofthe center portion 301, as shown in FIG. 3B. The location of the handletab 319 may be selected such that the handle 330 may be identical to thehandle 130 (i.e., a handle for a relatively short tray) and yet stillprotrude the same distance beyond the top surface 318 as the handle 130extends beyond the top surface 118. Consequently, the same handlecomponent may be used with multiple embodiments of the sterilizationtray 100 of varying height.

Various embodiments of the sterilization tray may include a cover.Referring to FIG. 3B for example, the sterilization tray 300 may alsoinclude a cover 340. The cover 340 may assist in retaining theinstruments 350 in place during transportation, handling, and thesterilization process. The cover 340 may include a plurality ofperforations 342 formed through the cover 340. The perforations 342 maybe circular in plan view or may be any shape that enables sterilizationfluids, such as super-heated steam, liquid sterilants, and oxidizingagents, to pass freely from one side of the cover 340 to the other.Likewise, the perforations 342 may be arranged in any manner thatenables the free flow of sterilization fluids but does not interferewith the structure and function of the tray 300. The cover 340 mayfurther include at least one, and typically two, handle openings 346formed through the cover 340 to enable the handle 330 to protrude beyondthe cover 340 and further to enable the handle 330 to provide anindexing feature when multiple trays 300 are stacked one upon another,as described herein.

Moreover, the cover 340 may include at least one, and typically two,locking tabs 344 to enable retention of the cover 340 to the tray 300.The locking tab 344 may be formed to engage at least one cover retentionopening 328 formed through either or both of the first and/or secondends 302, 303. The locking tab 344 may be formed to act as a leafspring, such that it is capable of flexing when pulled by a user awayfrom the tray 300, thereby disengaging the cover retention opening 328and enabling separation of the cover 340 from the tray 300. Furthermore,the cover 340 may include a skirt 348 formed along at least some portionof the periphery of the cover 340 and may have discontinuities at thecorners of the cover 430 as shown in FIG. 3B. The skirt 348 may engagethe first and second ends 302, 303 to provide indexing of the cover 340relative to the tray 300. In addition, the skirt 348 may providestructural support to reduce excessive flexing or twisting of the cover340.

Where a given set of instruments 150 is particularly heavy compared tothe flex strength of the sheet 110, a more robust sterilization tray 100may be required. For example, an instrument set suitable for hipreplacement surgery or shoulder surgery may generally be significantheavier than an instrument set appropriate for dental surgery. As shownin FIG. 5, a tray 500 may include a wire support frame 560 to stiffenand strengthen a sheet 510. The support frame 560 may be a single,integrated structure that includes at least one frame member 561 runningalong the longitudinal length of the tray 500 and may include integralhandles 530 formed at frame ends 502, 503. The sheet 510 may includeopenings 526 formed therethrough, such that the sheet 510 securelyengages the support frame 560. The sheet 510 may also include aplurality of end tabs 519 formed to engage the support frame 560 at ornear frame ends 502, 503. As shown in FIG. 5, end tabs 519 may wraparound a frame end member 562, thereby securing the sheet 510 to thesupport frame 560. Further, the sheet 510 may be riveted, welded, orotherwise attached to the support frame 560 at one or more places. Thesupport frame 560 may be formed from sections of bent wire joinedtogether.

In at least one embodiment according to the present disclosure, asterilization tray 600 may include a sheet metal support frame 660 tostiffen and strengthen a sheet 610, as shown in FIG. 6. The supportframe 660 may be a single, integrated structure that includes at leastone frame member 661 running along the longitudinal length of the tray600 and may further include integral handles 630 formed at frame ends602, 603. The at least one frame member 661 may be formed with bends andsimilar features to increase the stiffness of the sheet metal supportframe 660. The sheet 610 may be riveted, welded, or otherwise attachedto the support frame 660 at one or more places.

Alternatively, in at least one embodiment, a sterilization tray 700 mayinclude a support panel 770 to stiffen and strengthen a sheet 710 asshown in FIGS. 7A-7B. The support panel 770 may be formed of a singlesheet having first and second support ends 702, 703. The support ends702, 703 may be formed to accept and retain at least one handle 730 (notshown) as disclosed with respect to other embodiments herein. Thesupport panel 770 may also include a skirt 778 formed along at leastsome portion of the periphery of the support panel 770 to increase itsstiffness. The support panel 770 may further include a plurality ofopenings 774 formed through the support panel 770 that may be of anyshape or arrangement that enables the free flow of sterilization fluidsbut does not interfere with the structure and function of the supportpanel 770. In addition, the support panel 770 may include at least onelocking tab 772 to secure the sheet 710 to the support panel 770 asshown in FIG. 7A. The sheet 710 may be assembled to the support panel770 by flexing the sheet 710 such that its end edge fits beneath thelocking tab 772. The sheet 710 may then be released and, thus, will betrapped and retained between one of the support end portions 702, 703and the at least one locking tab 772. Alternatively, sheet 710 may beriveted, welded, or otherwise attached to the support panel 770 at oneor more places.

In at least one alternative embodiment, one or more handholds 726 may beformed integrally with the first and/or second ends 702, 703 by suitablyforming the support panel 770, thereby avoiding a need for the separatehandle 730. As shown in FIG. 7A, a handhold 726 may be formed in each ofthe first and second ends 702, 703 and adequately sized to enable a userto comfortably grasp and lift the tray 700. A comfort feature 725 may beformed in first or second end 702, 703 that includes a curl of materialextending inward and upward from the top edge of the handhold 726. Thecomfort feature 725 may be sized to provide the user with a smooth,rounded edge where the user's hand contacts the tray 700. Thesterilization tray 700 may include both one or more handholds 726 and atleast one handle 730, enabling a user to lift multiple stacked trays700, indexed and positioned by the handles 730, using the handholds 726of the lowermost tray. Likewise, as shown in FIG. 6, the tray 600 mayinclude one or more handholds 626 formed integral with the first andsecond ends 602, 603 of the sheet metal support frame 660. The one ormore handholds 626 similarly may include a comfort feature 625.Similarly, the tray 100 may include one or more handholds 128 formed inthe first and/or second ends 102, 103 of the sheet 110.

A sterilization tray of the present disclosure may include indiciaimprinted thereon. In at least one exemplary embodiment, as shown inFIG. 7B, the tray 700 may include indicia imprinted on a surface of thesheet 710 and/or the support panel 770. The indicia 711 may includeinstrument silhouettes, instrument and instrument set identifiers,manufacturer trademarks, and other indicia. The indicia 711 may beimprinted any suitable process.

In at least one embodiment, the sterilization tray 600 may include abridge 650. The bridge 650 may be a formed sheet adapted to nest withinopenings 620 and perforations 624 formed in the sheet 610. As shown inFIG. 6, the bridge 650 may span a trough 614 and engage a sheet 610 ator near one or more peaks 612. Accordingly, the bridge 650 may provideadditional configurations for supporting and retaining instruments. Forexample, the bridge 650 may enable the tray 600 to support and retainrelatively small instruments where the overall configuration of the tray600 is formed to be compatible with relative large instruments.

In at least one embodiment according to the present disclosure, asterilization tray 800 may include a waveform sheet 810 and a hinged lid840 with a latch 880 operable to lock the lid 840 in a closedconfiguration as shown in FIG. 8A. The lid 840 is shown in an openconfiguration in FIG. 8B. The lid 840 may include a first half 841 and asecond half 842. The first and second halves 841, 842 of the lid 840 maybe hinged to rotate about the sheet 810 between the open and closedconfigurations. In at least one embodiment, the lid 840 may be hinged toa support panel 870 as shown in FIG. 8A.

The first half 841 may be a formed sheet as shown in FIG. 8A.Alternatively, the first half 841 may include a lid frame 843 thatdefines the perimeter of the first half 841 and wraps around the sheet810 as shown in FIG. 8B, providing structure and support to the firsthalf 841. Likewise, the second half 842 may be a formed sheet as shownin FIG. 8A. Alternatively, the second half 842 may include a lid frame844 that defines the perimeter of the second half 842 and wraps aroundthe sheet 810 as shown in FIG. 8B, providing structure and support tothe second half 842. The first and second halves 841, 842 made bysecured together by the latch 880, thus securing the lid 840 in theclosed configuration. The latch 880 may include a first latch member 881and a second latch member 882 mounted to the first and second halves841, 842, respectively, that engage one another to secure the lid 840 inthe closed configuration. Alternatively, the latch 880 may be positionedon a first end 802 or a second end 803 instead of in the middle as shownin FIG. 8A. In an additional embodiment, the lid 841 may include onlyone half 841 that spans the entire width of the tray 800 and is securedon a side 804 by the latch 880.

The tray 800 may further include one or more posts 860 as shown in FIG.8A. The one or more posts 860 may extend from the support panel 870disposed below the sheet 810 toward openings 820 formed through thesheet 810 as shown in FIGS. 8A and 8B. The posts 860 may further extendthrough the openings 820 as shown in FIG. 8A. The posts 860 enablefurther positioning and retention of instruments 850 held in the tray800 and may be formed with a height selected for the specific instrument850 intended to be retained in a specific opening 820.

A plurality of sterilization trays, such as the tray 800, may bepackaged, transported, stored, and sterilized in a sterilization rack900. As shown in FIG. 9A, the rack 900 may be formed from a sheet 910having a first end 902, a second end 903, and a center portion 901therebetween. Similar to other embodiments disclosed herein, the sheet910 may include an undulating profile having at least one peak 912 andat least two troughs 914. The sheet 910 may further include a pluralityof openings 920 formed therethrough and configured to receive andsupport the tray 800 as shown in FIG. 9B. By varying the size andlocation of the openings 920, the rack 900 may be configured to receiveand support various embodiments of the tray 800. The tray 900 mayfurther include one or more handles 930 formed in the sheet 910.Alternatively, the one or more handles 930 may be formed of separatesheets of material and attached to the formed sheet 910. Accordingly,the rack 900 enables the efficient storage and transportation ofmultiple sterilization trays 800 in a configuration that further enablesthe trays 800 to be packaged together in a single sterile package.

The sterilization tray 100, and the various embodiments of the presentdisclosure, each represent a sterilization tray that is generallylighter in mass, has fewer components, is more easily manufactured andassembled, and is therefore less costly than conventional sterilizationtrays. Moreover, the undulating peaks and troughs of the sterilizationtrays according to the present disclosure support and retain theinstruments with minimal contact, which improves the efficacy of thesterilization process and reduces the amount of material needed to formthe tray. Further, the undulating peaks and troughs increase therigidity of the tray compared to a flat sheet having openings formedtherethrough. As a result, sterilization trays according to the presentdisclosure may be useful in various fields, and therefore the presentdisclosure is not limited to the medical applications noted herein.

The tray 100 may be formed in stainless steel, aluminum, or othersuitable non-corrosive material of adequate thickness. For example, thetray 100 may be formed in 300-series or 400-series stainless steelhaving a thickness of 0.036-0.075 inches. The structure of the tray 100may be formed using a laser cutting or punch press process to form theperforations 124 and all openings 120, 126 and 128, a deburring processto remove all sharp edges, a laser etching process to place instrumentsilhouettes, identifiers, and other indicia 771 on the surface of thesheet 110, and a press brake process to form the cross-sectional profileof the center portion 101 and the first and second ends 102, 103. Thecover 440, sheet metal support frame 660, and support panel 770 may beformed by means similar to the tray 100. Alternatively, the tray 100,handles 130, and cover 440 may be formed in a polymer-based materialthat is compatible with anticipated sterilization processes, using suchpolymer processing methods as injection molding, reaction molding andthe like.

FIGS. 10-21 illustrate a sterilization tray 1000 having an instrumentsegment 1100. The sterilization tray includes a first end 1002 and asecond end 1003, positioned opposite one another, and a center portion1001 that joins the first and second ends 1002, 1003 together. Unlessotherwise noted in the description of FIGS. 10-21, the sterilizationtray 1000 may include any of the features shown in FIGS. 1-9 anddescribed elsewhere herein. In one embodiment, each of the ends 1002,1003 includes and extension 1020 that extends upward from the tray 1000.At least one slot 1022 is formed in the extension 1020. While theillustrated embodiment shows two slots 1022, one of ordinary skill wouldrecognize that the extension 1020 may include any number of slots 1022.

A cover 1030 is provided to be placed on the tray 1000 so that theextensions 1020 of the tray 1000 are received within the cover 1030.Specifically, in one embodiment, the cover 1030 includes opposite ends1032. When the cover 1030 is positioned on the tray 1000, the extensions1020 of the tray 1000 are positioned adjacent the ends 1032 of the cover1030 along an interior surface 1034 of the cover ends 1032. In oneembodiment, the cover 1030 is constructed and arranged to lock to thetray 1000.

The cover 1030 includes an opening 1036 formed therein. In oneembodiment, the opening 1036 may be centered within the end 1032 of thecover 1030. The opening 1030 may include an upper corner member 1040 anda lower corner member 1042. The upper corner member 1040 and the lowercorner member 1042 may be rounded to eliminate sharp edges along theopening 1036.

A latch 1050 is positioned within the cover 1030. In one embodiment, thelatch 1050 includes an actuating member 1052 that is positioned withinthe opening 1036. A locking member 1054 extends from the actuatingmember 1052. The locking member 1054 may include a locking flange 1056extending therefrom. In the illustrated embodiment, the locking member1054 includes two locking flanges 1056 to correspond with the number ofslots 1022 formed in the extension 1020 of the tray 1000. It should berecognized that the locking member 1054 may include any number oflocking flanges 1056 to correspond to the number of slots 1022. Eachlocking flange 1056 includes an angled lower edge 1060. The latch 1050also includes at least one spring 1058 constructed and arranged to biasthe latch 1050 into a closed position, as described in more detailbelow.

In the closed position, the spring 1058 biases and secures the latch1050 so that the locking flanges 1056 are secured within the slots 1022of the tray 1000 to maintain a closed position as illustrated in FIGS.15, 16, 18, and 20. In this position, the cover 1030 is secured to thetray 1000 so that the cover 1030 may not be removed from the tray 1000unless the latch 1050 is actuated as described herein. To remove thecover 1030 from the tray 1000, a biasing force may be applied to theactuating member 1052 of the latch 1050. In one embodiment, the cover1030 includes a latch 1050 on each end 1032. Accordingly, in such anembodiment, a user may apply biasing force to the actuating member 1052of each latch 1050. As the latch 1050 is actuated, the latch 1050rotates so that the locking flanges 1056 become disengaged from theslots 1022 in an open position as is illustrated in FIGS. 17, 19, and21. In the open position, the user may grip the cover 1030 at the uppercorner member 1040, in one embodiment. As such the user may lift thecover 1030 from the tray 1000.

To position the cover 1030 back onto the tray 1000, the latches 1050 donot required direct biasing from the user, in one embodiment.Particularly, the cover 1030 may be centered on the tray 1000 so thatthe locking flanges 1056 are aligned with the slots 1022. By applyingdownward pressure on the cover 1020, the angled lower edges 1060 of thelocking flanges 1056 engage the extension 1020 of the tray 1000 so thatthe latches 1050 are biased into the open position allowing the cover1030 to move into engagement with the tray 1000. As the locking flanges1056 reach the slots 1022, the spring 1058 of the latch 1050 biases thelocking flanges 1056 of the latch 1050 into the slots 1022 to secure thecover 1030 to the tray 1000 in the closed position.

While various embodiments of a sterilization tray for instruments andmethods for using the same have been described in considerable detailherein, the embodiments are merely offered by way of non-limitingexamples of the disclosure described herein. It will therefore beunderstood that various changes and modifications may be made, andequivalents may be substituted for elements thereof, without departingfrom the scope of the disclosure. Indeed, this disclosure is notintended to be exhaustive or to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

What is claimed is:
 1. A system for storing instruments, the systemcomprising: a tray comprising at least one tray end, wherein at leastone slot is formed in the at least one tray end; an instrument segmentfitting within said tray, the instrument segment comprised of a singlesheet of a non-corrosive material, the single sheet of a non-corrosivematerial having a first segment end, an opposing second segment end, anda center segment portion between the first segment end and secondsegment end, wherein the center segment portion is formed with anundulating profile having a plurality of peaks and troughs and aplurality of segment openings formed therethrough, wherein the segmentopenings are positioned and formed to receive one or more medicalinstruments, the instrument segment further comprising a bridge, thebridge comprising a plurality of bridge openings formed therethrough anddisposed between adjacent peaks of the instrument segment, therebyspanning a corresponding trough, wherein the bridge openings arepositioned and configured to receive the one or more instruments; acover constructed and arranged to be positioned on the tray in a mannerenclosing said instrument segment within a cavity formed by the coverpositioned on the tray, the cover comprising at least one cover end; anda latch positioned within the at least one cover end, the latchcomprising a locking flange constructed and arranged to be received inthe at least one slot, wherein the at least one locking flange includesan angled lower edge constructed and arranged to engage the at least oneslot when the cover is positioned on the tray.
 2. The system of claim 1,wherein at least a portion of the at least one tray end is positionedwithin the cover when the cover is positioned on the tray.
 3. The systemof claim 1, wherein the at least one tray end farther comprises anextension, the at least one slot formed in the extension.
 4. The systemof claim 3, wherein the extension of the at least one tray end ispositioned adjacent the at least one cover end when the cover ispositioned on the tray.
 5. The system of claim 3 further comprising alatch opening formed in the cover, wherein the latch further comprisesan actuating member, the actuating member of the latch positioned withinthe latch opening.
 6. The system of claim 5 further comprising an uppercorner member disposed on a perimeter of the latch opening to enable auser to grip the cover.
 7. The system of claim 1, wherein the latchfurther comprises an actuating member, and wherein the latch isconstructed and arranged to receive a force on the actuating member tomove the latch from a closed position wherein the at least one lockingflange is engaged with the at least one slot and an open positionwherein the at least one locking flange is disengaged from the at leastone slot.
 8. The system of claim 1 further comprising a spring to biasthe latch into a closed position.
 9. The system of claim 1, wherein thecenter segment portion comprises a corrugated profile.
 10. The system ofclaim 1, wherein the center segment portion comprises a profile selectedfrom the group consisting of: saw-tooth and triangular.
 11. The systemof claim 1, wherein a distance between adjacent peaks of the centersegment portion defines a wave having a profile and a length, andwherein the center segment portion is comprised of one or more waves ofnon-uniform profile and varying lengths.
 12. The system of claim 1,wherein the plurality of segment openings are formed such that the oneor more instruments lie substantially on a plane across the peaks andtroughs of the center segment portion.
 13. The system of claim 1,wherein the segment openings are formed such that there is a clearancebetween each segment opening and each of the corresponding one or moreinstruments.
 14. The system of claim 1, wherein the instrument segmentfurther comprises a plurality of perforations formed through the segmentand disposed between the segment openings.
 15. The system of claim 1,wherein a plurality of instrument segments may be stacked one uponanother.
 16. The system of claim 1, wherein the one or more instrumentscomprise a set of surgical instruments.
 17. The system of claim 1,wherein the instrument segment comprises a polymeric material compatiblewith sterilization fluids and sterilization processes.
 18. The system ofclaim 1, wherein the instrument segment comprises a non-corrosivematerial comprising a metal selected from the group consisting of:stainless steel and aluminum.